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Notification

Found : 17
  Body (History):

National Standards Authority of Ireland (NSAI)
1 Swift Square, Northwood, Santry
Dublin 9
Country : Ireland

Phone : +353.1.807.38.00
Fax : +353.1.807.39.25

Email : info@nsai.ie
Website : www.nsai.ie

Notified Body number : 0050

Version(s): 1 2 3 4 5 6 7

Last update : 25/02/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
98/79/EC In vitro diagnostic medical devices    
Last update : 01/03/2011                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
*IVD 0300 - Reagents, reagent products and devices for self-diagnosis, including related calibrators and control materials, for determining, detection, quantification, diagnosing, evaluating
 
   - *IVD 0301 - Anti-Duffy and anti-Kidd
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0302 - Irregular anti-erythrocytic antibodies
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0303 - Congenital infections: rubella, toxoplasmosis
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0304 - Hereditary disease: phenylketonuria
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0305 - Human infections: cytomegalovirus, chlamydia
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0306 - HLA tissue groups: DR, A, B
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0307 - Tumoral marker: PSA
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0308 - Risk of trisomy 21 (incl. software)
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
*IVD 0400 - Devices for self-testing
 
   - *IVD 0401 - Clinical chemistry
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0402 - Haematology
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0403 - Immunology
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0404 - Molecular biology
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0405 - Pregnancy and ovulation
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0406 - Specimen receptacles
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
 
Horizontal technical competence Limitations
*MDS 7206 - IVDs in sterile condition  
*MDS 7207 - IVDs utilising micromechanics  
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